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The Aequalis™ PerFORM™ Reversed Glenoid and Aequalis™ PerFORM™+ Reversed Glenoid are indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and non-repairable rotator cuff-tear with pain disabled by:

• · Rheumatoid arthritis
• · Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
• · Correction of functional deformity
• · Fractures of the humeral head
• · Traumatic arthritis
• Revision of the devices if sufficient bone stock remains

The Aequalis™ PerFORM™ Reversed Glenoid and Aequalis™ PerFORM™+ Reversed Glenoid shoulder system is a modular system consisting of a Glenoid Component Assembly and a Humeral Component Assembly for total shoulder arthroplasty. The associated shoulder surgical instruments are intended to facilitate proper implantation of this shoulder system. The Aequalis™ PerFORM™ Reversed Glenoid and Aequalis™ PerFORM™+ Reversed Glenoid shoulder system is designed and indicated for replacement of the shoulder joint to reduce pain and improve shoulder mobility in comparison with preoperative status.

Unfortunately, I cannot fulfill your request to provide a detailed table of acceptance criteria and reported device performance, information about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details.

The provided document is a 510(k) summary from the FDA for a medical device (Aequalis™ PerFORM™ Reversed Glenoid and Aequalis™ PerFORM™+ Reversed Glenoid). While it states that non-clinical bench testing and process validations were performed to demonstrate substantial equivalence, it does not include the detailed acceptance criteria or the specific results of these tests.

The document merely states that:

• "The addition of a short Press-fit Post to the Aequalis™ PerFORM™ Reversed Glenoid and Aequalis™ PerFORM™+ Reversed Glenoid shoulder system meets the device testing acceptance criteria described in the predicate submission (K161742), and is substantially equivalent to predicate long Press-fit Post."
• "Both the short and the long Press-fit Posts can be configured with the Half-Wedge Augment Baseplate and Full-Wedge Augment Baseplate. These configurations meet the appropriate acceptance criteria."

This document focuses on the regulatory clearance process based on substantial equivalence to a predicate device (K161742), rather than a detailed report of the performance study itself. It explicitly states that "Clinical studies were not required to demonstrate substantial equivalence between the subject device and the predicate device."

To obtain the information you're looking for, you would typically need to review the full 510(k) submission (which is much more extensive than this summary) or potentially the predicate device's submission (K161742) if the acceptance criteria are indeed described there.

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